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Last Updated: December 9, 2019

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Risperidone - Generic Drug Details

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What are the generic sources for risperidone and what is the scope of patent protection?

Risperidone is the generic ingredient in four branded drugs marketed by Indivior Inc, Janssen Pharms, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Precision Dose, Taro, Torrent, Tris Pharma Inc, West-ward Pharms Int, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Heritage Pharma, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Celltrion, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-nine NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has one hundred patent family members in twenty-eight countries.

There are thirty drug master file entries for risperidone. Forty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for risperidone

See drug prices for risperidone

Drug Sales Revenue Trends for risperidone

See drug sales revenues for risperidone

Recent Clinical Trials for risperidone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Glostrup University Hospital, CopenhagenPhase 2
Copenhagen University Hospital, DenmarkPhase 2
University of CopenhagenPhase 2

See all risperidone clinical trials

Recent Litigation for risperidone

Identify potential future generic entrants

District Court Litigation
Case NameDate
Alkermes Pharma Ireland Limited v. Luye Pharma Group Ltd.2019-07-17
United States v. Indivior Inc.2019-04-09
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13

See all risperidone litigation

PTAB Litigation
PetitionerDate
Luye Pharma Group Ltd.2016-05-31

See all risperidone litigation

Generic filers with tentative approvals for RISPERIDONE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1MG/MLSOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for risperidone
Medical Subject Heading (MeSH) Categories for risperidone
Synonyms for risperidone
(risperidone)3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-a]pyrimidin-4-one
1026102-43-1
106266-06-2
2-(2-(4-(benzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-7,8,9,9a-tetrahydro-1H-pyrido[1,2-a]pyrimidin-4(6H)-one
2-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-6,7,8,8a-tetrahydro-5H-naphthalen-1-one
3-?[2-?[4-?(6-?fluoro-?1,?2-?benzisoxazol-?3-?yl)?-?1-?piperidinyl]?ethyl]?-?2,?3,?6,?7,?8,?9-?hexahydro-?2-?methyl-4H-?Pyrido[1,?2-?a]?pyrimidin-?4-?one
3-(2-(4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino)ethyl)-6,7,8,9-tetrahydro-2-methyl-4H-pyrido(1,2-a)pyrimidin-4-one
3-(2-(4-(6-Fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
3-[2-[-4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6 fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-fluoranyl-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-fluoro- 1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl4H-pyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidiny]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido [1,2-a] pyrimidin-4-one
3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]-ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-A]pyrimidin-4-one
3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperi-dino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]-pyrimidin-4-one
3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)-1-piperidinyl]ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)-1-piperidyl]ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[2,1-b]pyrimidin-4-one
3-[2-[4(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
3-[2-[4(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl4H-pyrido[1,2-a]pyrimidin-4-one
3-{2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl}-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimid-in-4-one
3-{2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl}-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
3-{2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
3-{2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl}-6,7,8,9-tetrahydro-2-methylpyrido[1,2-a]pyrimidin-4-one
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4H,6H,7H,8H,9H-pyrido[1,2-a]pyrimidin-4-one
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
3-{2-[4-(6-FLUORO-BENZO[D]ISOXAZOL-3-YL)-PIPERIDIN-1-YL]-ETHYL}-2-METHYL-6,7,8,9-TETRAHYDRO-PYRIDO[1,2-A]PYRIMIDIN-4-ONE
3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-a]pyrimidin-4-one (Resperidone)
3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-a]pyrimidin-4-one (risperidone)
3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-a]pyrimidin-4-one(risperidone)
3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
3-{2-[4-(6-fluorobenzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
4767-EP2269990A1
4767-EP2272537A2
4767-EP2272841A1
4767-EP2275420A1
4767-EP2275423A1
4767-EP2280008A2
4767-EP2280010A2
4767-EP2298731A1
4767-EP2298776A1
4767-EP2301936A1
4767-EP2308867A2
4767-EP2308870A2
4767-EP2308875A1
4767-EP2316836A1
4H-Pyrido(1,2-a)pyrimidin-4-one, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6 ,7,8,9-tetrahydro-2-methyl-
4H-Pyrido(1,2-a)pyrimidin-4-one, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-2-methyl-
4H-Pyrido(1,2-a)pyrimidin-4-one, 6,7,8,9-tetrahydro-3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-2-methyl-
4H-Pyrido[1,2-a]pyrimidin-4-one, 3-[2-[4-(6-fluoro-1,2-benz-isoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-
4H-Pyrido[1,2-a]pyrimidin-4-one, 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-
5-[2-(4-Benzo[d]isothiazol-3-yl-piperazin-1-yl)-ethyl]-6-methyl-1,3-dihydro-indol-2-one(Norastemizole)
66R062
A801409
AB0004623
AB00514010
AB00514010_13
AB00514010_14
AB00514010-09
AB00514010-11
AB00514010-12
AC-1306
AC1L1JJU
ACT04270
AKOS005577302
AN-15065
ANW-42874
Apexidone
API0004081
BC206675
BCP08161
BDBM50001885
Belivon
BG0309
BIDD:GT0262
BRD-K53857191-001-04-5
BRD-K53857191-001-10-2
BRN 4891881
C-21900
C23H27FN4O2
CAS-106266-06-2
CC-34268
CCG-100930
CHEBI:8871
CHEMBL85
CPD000466323
CR0023
CS-1619
D00426
DB00734
DSSTox_CID_25193
DSSTox_GSID_45193
DSSTox_RID_80740
DTXSID8045193
EU-0101074
FT-0631037
GTPL96
HMS1571M19
HMS2051H07
HMS2089C22
HMS2098M19
HMS2233O11
HMS3373M18
HMS3393H07
HMS3657G13
HMS3715M19
HSDB 7580
HY-11018
I01-1156
J-001555
J10290
Jsp000573
KS-00000760
KS-1106
L000510
L6UH7ZF8HC
Lopac-R-118
LS-134196
MCULE-4027175053
MFCD00274576
MLS000759429
MLS001165758
MLS001424081
MolPort-002-885-858
NC00180
NCGC00015883-01
NCGC00015883-02
NCGC00015883-03
NCGC00015883-04
NCGC00015883-05
NCGC00015883-06
NCGC00015883-07
NCGC00015883-08
NCGC00015883-11
NCGC00094352-01
NCGC00094352-02
NCGC00094352-03
NCGC00179257-01
NP-202
NSC-759895
NSC759895
PB26023
Pharmakon1600-01506038
Prestwick0_001029
Prestwick1_001029
Psychodal
PYR332
Q-4040
R 62 766
R 64 766
R 64,766
R 64766
R-118
R-64-766
R-64766
R0087
RAPZEAPATHNIPO-UHFFFAOYSA-N
Relday
Rispen
Risperdal
Risperdal (TN)
Risperdal Consta
Risperdal M-Tab
risperdone
Risperidal
Risperidal M-Tab
Risperidona
Risperidona [Spanish]
Risperidone (JP17/USAN/INN)
Risperidone (RIS)
Risperidone (Risperdal)
Risperidone [USAN:BAN:INN]
Risperidone [USAN:USP:INN:BAN]
Risperidone 1.0 mg/ml in Methanol
Risperidone for system suitability, European Pharmacopoeia (EP) Reference Standard
Risperidone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Risperidone-ISM
Risperidone, >=98% (HPLC), powder
Risperidone, 99%
Risperidone, British Pharmacopoeia (BP) Reference Standard
Risperidone, European Pharmacopoeia (EP) Reference Standard
Risperidone, Pharmaceutical Secondary Standard; Certified Reference Material
Risperidone, placebo
Risperidone, United States Pharmacopeia (USP) Reference Standard
Risperidone(R 64 766)
Risperidonum
Risperidonum [Latin]
Risperin
Rispolept
Rispolin
RTR-001241
s1615
SAM001246595
SC-16313
SCHEMBL27911
Sequinan
SMR000466323
SPBio_003078
Spiron
SR-01000075399
SR-01000075399-2
SR-01000075399-8
STK646402
SW197348-4
TL8000230
Tox21_110253
Tox21_110253_1
TR-001241
UNII-L6UH7ZF8HC
US8802672, Risperidone
Z1522566617
ZINC538312
Zophrenal
Paragraph IV (Patent) Challenges for RISPERIDONE
Tradename Dosage Ingredient NDA Submissiondate
RISPERDAL TABLET, ORALLY DISINTEGRATING;ORAL risperidone 021444 2005-04-11
RISPERDAL TABLET, ORALLY DISINTEGRATING;ORAL risperidone 021444 2005-03-23
RISPERDAL SOLUTION;ORAL risperidone 020588
RISPERDAL TABLET;ORAL risperidone 020272

US Patents and Regulatory Information for risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising RISPERIDONE risperidone TABLET;ORAL 078269-001 Oct 8, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharma RISPERIDONE risperidone TABLET;ORAL 077769-006 Oct 16, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharma RISPERIDONE risperidone TABLET;ORAL 076228-005 Jun 30, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Janssen Pharms RISPERDAL risperidone TABLET;ORAL 020272-007 Jan 27, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007   Start Trial   Start Trial
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-001 Apr 2, 2003   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for risperidone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0196132 94C0008 Belgium   Start Trial PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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